Do I need to coat omeprazole pellets? Can I just add the right colour to the formulation?

I want to make omeprazole pellets. Is it really necessary to coat them with a special coating? Can’t I just add the right colour to the formulation?

We have been asked by a manufacturer (interested in looking at the development of Omeprazole formulations) if it was really necessary to coat these pellets with an enteric coating.

Omeprazole formulations are generally made into small pellets from about 0.7 to about 1.4 mm in diameter These are generally given an enteric coating on the individual pellets (or spheroids). An enteric coating generally means a coating that will prevent the disintegration or dissolution of the pellets in the acidic environment found in the stomach (pH approximately 3). The active ingredient in the pellets is rapidly degraded in the acidic medium of the stomach.

Once the capsules are broken or dissolved in the stomach then the small pellets or microspheres behave like liquids and quickly move through the pyloric sphincter to the small intestine. The environment in the small intestine is more alkaline (pH 7 to 9) and in this environment the enteric coat is dissolved and the active ingredient released into an environment where it is stable and so can be absorbed into the body. Tablets would generally stay in the stomach longer and so simply putting an enteric coating on a tablet would not have the same effect.

So briefly and mainly for the reason mentioned above the answer to this is most definitely “yes, you do need to add an enteric coat to your omeprazole pellets”. Talk to us if you want to have more information.